FDA targets illegal online opioid retailers in new overdose prevention framework

Regulatory NewsRegulatory News | 30 August 2022 |  By 

FDA Commissioner Robert Califf (Source: FDA)

The US Food and Drug Administration (FDA) said it plans to fight the current opioid crisis by going after online drug retailers and promoting the development of non-opioid alternatives.
On 30 August, the agency published its FDA Overdose Prevention Framework that largely aligns with the Department of Health and Human Service’s (HHS) 2021 Overdose Prevention Strategy. The framework echoes concepts in the HHS strategy, such as supporting primary prevention, encouraging harm reduction and advancing evidence-based treatments. FDA’s framework also includes the actions to protect the public from unapproved, diverted and counterfeit drugs with overdose risk.
In a blog post, FDA Commissioner Robert Califf said the agency needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs and methamphetamines on the market. Cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority, he said.
Califf added that FDA will also further its surveillance, enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products at international mail facilities, express courier hubs and ports of entry across the nation.
“We will build on our surveillance, compliance, and enforcement actions, including to address health fraud such as [substance use disorder (SUD)] treatment claims,” said Califf. “This includes joint interdiction operations with other federal agencies such as Customs and Border Protection.”
FDA has recently stepped up its efforts by going after online retailers selling unapproved or misbranded drugs, often without requiring prescriptions or following federal regulations.
In 2020, FDA completed a pilot program that included three major registries and the National Telecommunications and Information Administration (NTIA) to crack down on websites selling unapproved opioids online which successfully shut down nearly 30 such sites. Califf noted that in April 2022, FDA and the Drug Enforcement Agency partnered for the first time to go after two websites illegally selling schedule II stimulants, including amphetamine drug products marketed as Adderall.
More recently, FDA also issued warning letters to a mysterious online drug retailer that is linked to more than two dozen web sites that sell unapproved and misbranded opioids, and other drugs. (RELATED: FDA warns network of websites for unlawfully selling opioids, benzodiazepines, Regulatory Focus 23 August 2022)
Under the new framework, FDA is exploring several strategies to support primary prevention, such as improving training for opioid analgesic prescribers.
“Prescriber education is not new, and there has been a consistent reduction in the prescription of opioids in the U.S.,” said Califf. “But we are taking a fresh look at how to make prescriber education more effective and link it to behavioral change in optimizing appropriate prescribing and use of alternative interventions to treat pain.”
He said the agency is exploring the need for new authorities for opioid approval standards, including whether new opioid analgesic drug sponsors should be required to show that their products offer safety advantages over existing approved opioid analgesics.
Earlier this year FDA published a draft guidance offering advice on developing of non-opioid pain relievers for acute pain and it plans to publish a similar guidance on non-addictive treatments for chronic pain. The agency hopes the guidances will help spur new pain treatments, especially considering the current dearth of options. (RELATED: Opioid alternatives: FDA offers insights on developing non-addictive drugs for acute pain, Regulatory Focus 9 February 2022)
“Throughout my career and during my first stint as commissioner, I supported the development of FDA guidances and definitive evidence-based documents,” said Califf. “These elements can help stimulate other critical constituencies to take actions within their control and I intend to use this approach aggressively as we work together on prevention.”
When it comes to encouraging harm reduction FDA has sought to improve access to the opioid overdose treatment naloxone. The agency has held public meetings on how to expand its use and get it into the hands of people, including law enforcement, to prevent overdose deaths but state laws have often been a barrier. Despite that, FDA said it will continue to encourage drug-makers to develop over-the-counter (OTC) naloxone which the agency said is a high priority.
“The FDA continues to encourage and advise industry in the development of OTC naloxone… However, the FDA recognizes that the transition from prescription to OTC naloxone status may impact health insurance coverage, and has the potential to create other unintended barriers to access,” said Califf. “This is an issue we are actively examining with our federal colleagues.”
As part of the framework, the commissioner said FDA will continue to support development of new interventions as part of the agency’s efforts to advance evidence-based treatments for substance use disorders (SUD). In particular, he highlighted the potential that digital interventions and other medical devices may play.
FDA plans to publish a draft guidance titled, Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder and build on what it learned from its October 2021 virtual public workshop on developing new treatments for SUD.


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